search
Back to results

Trial of Single Agent AZD2014 in RICTOR Amplified GC Patients as Second-line Therapy (AZD2014)

Primary Purpose

Stomach Neoplasms

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AZD2014
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after firstline therapy.
  4. Previous adjuvant/neoadjuvant chemotherapy is allowed, if completed more than 6 months prior to starting the 1st line therapy.
  5. Provision of tumor sample (from either a resection or biopsy)
  6. Patients with RICTOR amplification or overexpression through the VIKTORY trial.
  7. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  8. ECOG performance status 0-2.
  9. Patients must have a life expectancy ≥ 3 months from proposed first dose date.
  10. Patients must have acceptable bone marrow, liver and renal function -
  11. At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits.
  12. Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1.

Exclusion Criteria:

  1. More than one prior chemotherapy regimen for the treatment of gastric cancer in the advanced setting.
  2. Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity.
  3. Patients with second primary cancer,
  4. Patients unable to swallow orally administered medication.
  5. Previous major surgery within 4weeks prior to enrollment.
  6. For AZD2014: Exposure to potent or moderate inhibitors or inducers of CYP3A4/5 if taken within the stated washout periods before the first dose of study treatment Inhibitors
  7. Exposure to potent or moderate inhibitors or inducers of CYP2C8 if taken within the stated washout periods before the first dose of study treatment
  8. With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy.
  9. Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
  10. Resting ECG with measurable QTcB > 450 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
  11. Patients with cardiac problem
  12. Active or untreated brain metastases or spinal cord compression Patients with treated brain metastases or spinal cord compression are eligible if they have minimal neurologic symptoms, evidence of stable disease (for at least 1 month) or response on follow-up scan, and require no corticosteroid therapy for ≥ 1 week.
  13. Female patients who are breast-feeding or child-bearing
  14. Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
  15. Patients with proteinuria (3+ on dipstick analysis )

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AZD2014 50mg BD continuous schedule of a 28 day cycle

Arm Description

AZD2014 50mg BD continuous schedule of a 28 day cycle

Outcomes

Primary Outcome Measures

Objective response rate (ORR) by RECIST 1.1

Secondary Outcome Measures

Full Information

First Posted
February 10, 2017
Last Updated
May 17, 2019
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03061708
Brief Title
Trial of Single Agent AZD2014 in RICTOR Amplified GC Patients as Second-line Therapy
Acronym
AZD2014
Official Title
Phase II Trial of Single Agent AZD2014 in RICTOR Amplified or Over-expressed GC Patients as Second-line Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
lack of efficacy
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
November 16, 2018 (Actual)
Study Completion Date
November 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase II trial of AZD2014 in RICTOR amplified or overexpressed GC patients as second-line chemotherapy AZD2014 50mg BD continuous schedule of a 28 day cycle
Detailed Description
Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date). Study treatment will be continued until objective disease progression (unless other criteria for 3 treatment discontinuation are met). Patients may continue AZD2014 beyond progression (according to RECIST 1.1), at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria. If a patient discontinues study treatment prior to disease progression, they should continue to be assessed using RECIST 1.1 until disease progression and then followed up for survival. Assessments for survival should be made every 8 weeks following objective disease progression. The details of first and subsequent therapies for cancer, after discontinuation of treatment, will be collected. The imaging modalities used for RECIST 1.1 assessment will be CT or MRI scans of chest, abdomen and pelvis. RECIST 1.1 scans will be analysed by the investigator on site.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
AZD2014 50mg BD continuous schedule of a 28 day cycle
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD2014 50mg BD continuous schedule of a 28 day cycle
Arm Type
Experimental
Arm Description
AZD2014 50mg BD continuous schedule of a 28 day cycle
Intervention Type
Drug
Intervention Name(s)
AZD2014
Intervention Description
mTOR inhibitor
Primary Outcome Measure Information:
Title
Objective response rate (ORR) by RECIST 1.1
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of fully informed consent prior to any study specific procedures. Patients must be ≥20 years of age. Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after firstline therapy. Previous adjuvant/neoadjuvant chemotherapy is allowed, if completed more than 6 months prior to starting the 1st line therapy. Provision of tumor sample (from either a resection or biopsy) Patients with RICTOR amplification or overexpression through the VIKTORY trial. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. ECOG performance status 0-2. Patients must have a life expectancy ≥ 3 months from proposed first dose date. Patients must have acceptable bone marrow, liver and renal function - At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits. Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Exclusion Criteria: More than one prior chemotherapy regimen for the treatment of gastric cancer in the advanced setting. Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity. Patients with second primary cancer, Patients unable to swallow orally administered medication. Previous major surgery within 4weeks prior to enrollment. For AZD2014: Exposure to potent or moderate inhibitors or inducers of CYP3A4/5 if taken within the stated washout periods before the first dose of study treatment Inhibitors Exposure to potent or moderate inhibitors or inducers of CYP2C8 if taken within the stated washout periods before the first dose of study treatment With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy. Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment. Resting ECG with measurable QTcB > 450 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome. Patients with cardiac problem Active or untreated brain metastases or spinal cord compression Patients with treated brain metastases or spinal cord compression are eligible if they have minimal neurologic symptoms, evidence of stable disease (for at least 1 month) or response on follow-up scan, and require no corticosteroid therapy for ≥ 1 week. Female patients who are breast-feeding or child-bearing Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV) Patients with proteinuria (3+ on dipstick analysis )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeeyun Lee, Md,PhD
Organizational Affiliation
SamsungMedicalCenter
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Trial of Single Agent AZD2014 in RICTOR Amplified GC Patients as Second-line Therapy

We'll reach out to this number within 24 hrs